Children's Adaptive Deep Brain Stimulation for Epilepsy Trial (CADET): Pilot

NCT05437393 | Completed DMC

• 1 other identifier: 141267
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

Brief Summary

The CADET Pilot will investigate the safety and feasibility of deep brain stimulation (DBS) to treat children with Lennox-Gastaut syndrome using a novel DBS device (Picostim DyNeuMo-1). Following a 30-day preoperative/baseline assessment phase, all children will have a neurosurgical procedure to implant the device. Implantation will be followed by a 30-day phase of no stimulation (the device is off / inactive) and then a six-month phase of active stimulation (the device is on / active).

Conditions

Epilepsy; Lennox-Gastaut Syndrome, Intractable

Keywords

Deep brain stimulation; Neurostimulation; Neuromodulation; Epilepsy; Lennox-Gastaut Syndrome

Outcome Measures

Primary Outcomes (4)

• Adverse evens

  Measured according to pre-determined device-related AEs and SAEs, as well as generic AEs and SAEs.

  Following 6-months of active stimulation

• Willingness of the participants/parents/guardians for the participant to be recruited into the study and to undergo the intervention

  Consent at baseline

  Following 6-months of active stimulation

• Participant completion of the study

  Completion of all study activities at study exit

  Following 6-months of active stimulation

• Ability of the participant/parent(s)/guardian(s) to re-charge and maintain the device

  Device recharging is measured using the Picostim event logs

  Following 6-months of active stimulation

Secondary Outcomes (5)

• Relative change in parent-reported seizure frequency

  Following 6-months of active stimulation (compared to baseline)

• Relative change in electrographic-recorded seizure frequency

  Following 6-months of active stimulation (compared to baseline)

• Relative change in seizure severity

  Following 6-months of active stimulation (compared to baseline)

• Relative change in quality of life

  Following 6-months of active stimulation (compared to baseline)

• Relative change in quality of life

  Following 6-months of active stimulation (compared to baseline)

Other Outcomes (2)

• Radiological correlates of neurophysiological and clinical response to CMN DBS

  Following 6-months of active stimulation

• Correlates of the scalp EEG with the intracranial recordings (local field potentials) from the DBS device.

  Following 6-months of active stimulation

Study Arms (1)

Deep brain stimulation

EXPERIMENTAL

Deep Brain stimulation using a novel device: Bioinduction "Picostim" Deep Brain Stimulation system.

Device: Deep brain stimulation

Interventions

Deep brain stimulation DEVICE

Deep brain stimulation of the centromedian nucleus (bilateral)

Deep brain stimulation

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children enrolled in this study must:
• Be 5-14 years of age at consent.
• Have a diagnosis of Lennox-Gastaut Syndrome, as determined by:
• Slow (\<3.0Hz) spike-and-wave pattern and/or fast wave pattern (tonic seizures) on EEG for at least six-months months prior to the enrolment into the baseline period
• History of drop seizures (tonic, atonic, or tonic-clonic) for at least six-months prior to the enrolment into the baseline period
• Experience at least 10 seizures per month.
• Have tried and not responded to two or more antiseizure medications prior to enrolment.
• Be taking one or more anti-seizure medication(s) at a stable dose for at least the four weeks prior and have a parent/guardian(s) who is willing for their child's maintenance anti-seizure drugs to be unaltered for the trial duration.
• If on a ketogenic diet, have been established on a stable ketogenic diet for at least 12 weeks prior to screening and the parent/guardian(s) to be willing for child to stay on a stable ketogenic for the duration of the trial.
• Have a parent/guardian(s) who is willing and able to comply with all the requirements of the study, including the completion of the seizure diary and periodic device charging.
• \-------------------------------

You may not qualify if:

• Children enrolled in this study must not:
• Have had prior deep brain stimulation insertion.
• Have an active ('on') vagus nerve stimulator (or active within the six months prior to the baseline period).
• Have abnormal thalamic anatomy detected on imaging that would render DBS either unsafe or unfeasible.
• Have a bleeding disorder.
• Have medical conditions/factors that would increase their anaesthetic risk to an unacceptable level.
• Have a nickel allergy
• Be pregnant
• Participate in contact sports

Sponsors & Collaborators

• University College, London: lead
• Great Ormond Street Hospital for Children NHS Foundation Trust: collaborator
• King's College Hospital NHS Trust: collaborator
• University of Oxford: collaborator
• King's College London: collaborator

Study Sites (2)

Great Ormond Street Hospital NHS Foundation Trust

London, United Kingdom

Location

King's College Hospital NHS Foundation Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Epilepsy; Lennox Gastaut Syndrome

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: June 29, 2022
• Study Start: June 2, 2023
• Primary Completion: August 26, 2025
• Study Completion: August 26, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)